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The supplemental biologics license application (sBLA) will propose a label expansion to include use of the Zevalin therapeutic regimen ((90Y)-ibritumomab tiuxetan) as consolidation therapy after remission induction in

The first application to be addressed under this agreement will include adaptive gating, the capability of automatically interrupting the radiation beam from a linear accelerator in response to

Following the recommendation for regulatory approval under the European decentralized procedure, Toctino received national regulatory approval in Denmark. The Danish Medicines Agency approved label for Toctino indicates ‘for

The primary objectives of the study are to evaluate acute and chronic quality-of-life assessments and complications related to external beam radiation therapy in prostate cancer patients when the

The multicenter trial will test the efficacy, safety and tolerability of once-daily doses of 200, 300 and 400mg of TR-701 in complicated skin and skin structure infections (cSSSI)

Alcon is currently in the planning and design phase of the project and will spend more than $25 million during the first phase of development. The new 74,000sqft

The launch of Erbitux in Japan is the result of a co-development and co-commercialization agreement between ImClone, Bristol-Myers Squibb Company and Merck KGaA, Darmstadt, Germany. Bristol-Myers Squibb and

The Phase IIa randomized, placebo-controlled clinical trial is evaluating the safety and immunogenicity of different doses of its seasonal influenza virus-like particle (VLP) vaccine. Specifically, the vaccine will

The orphan drug designation will entitle Enobia to a seven-year period of marketing exclusivity for the drug upon FDA approval, as well as the opportunity to apply for